Dietary intervention for gastroparesis in systemic sclerosis
Research type
Research Study
Full title
Pilot study to investigate tolerability and efficacy of dietary manipulation in patients with gastroparesis and systemic sclerosis
IRAS ID
227397
Contact name
Theresa Barnes
Contact email
Sponsor organisation
Countess of Chester Hospital
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Systemic sclerosis is an autoimmune condition characterised by deposition of collagen within the skin and systemic tissues. The gastrointestinal tract is the second most commonly affected organ in systemic sclerosis and deposition of collagen within the stomach can lead to gastroparesis (delayed gastric emptying). The development of gastroparesis can lead to significant morbidity and mortality and is associated with gastrointestinal symptoms including upper abdominal pain, nausea and vomiting, bloating and poor appetite and nutritional consequences such as weight loss and micronutrient deficiencies. Few studies have investigated interventions with the aim of improving symptoms and reducing nutritional impact. The purpose of our pilot study is to investigate the tolerability and efficacy of implementation of a gastroparesis-specific diet over a one month period in patients with gastroparesis and systemic sclerosis. Our primary aim is to investigate adherence to the diet (measured by monitoring food intake during the course of the trial with subject completed food diaries). We will also investigate whether dietary changes can lead to improved gastrointestinal symptoms, increased weight, reduced malnutrition scores and improve blood parameters of nutrition. If the diet is found to be tolerable and effective, our work has the potential to improve symptoms and nutrition in patients with systemic sclerosis and can be extrapolated to patients with other forms of gastroparesis.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
17/NW/0480
Date of REC Opinion
8 Sep 2017
REC opinion
Further Information Favourable Opinion